Study Provides Favorable Evidence for 4-D CT-ventilation Functional Avoidance

Presenting author:
Yevgeniy Vinogradskiy, PhD

By Teh Lin, PhD, Associate Professor, Fox Chase Cancer Center

Advances in early diagnosis of lung cancer have increased the interest in preserving post-radiation therapy lung function. Functional imaging has been proposed that uses four-dimensional computer tomography (4-D CT) images to calculate 4-D CT-based lung ventilation (4-D CT-ventilation) before treatment. Representing the clinical trial team from the University of Colorado and the Beaumont Health System (NCT02528942), Yevgeniy Vinogradskiy, PhD, presents important data on reducing grade 2 and higher radiation pneumonitis rates by utilizing functional avoidance radiotherapy structures. Dr. Vinogradskiy, now at Thomas Jefferson University, presented the abstract Results of a Multi-Institutional Phase II Clinical Trial for 4-D CT-Ventilation Functional Avoidance Thoracic Radiotherapy during the 2021 Annual Meeting.

Dr. Vinogradskiy also presented some preliminary data at this year’s AAPM titled Functional Image--guided Targeting and Avoidance in Radiation Therapy. He mentioned this clinical trial would like to evaluate the feasibility and efficacy of incorporating avoiding heavily ventilated lung areas into the dose delivery and to compare those of grade 2 and above radiation pneumonitis rates to the overall lung radiation treatment to improve the patient’s quality of life. “A phase II, multi-center, prospective study was initiated to evaluate 4-D CT-ventilation functional avoidance radiotherapy. The study hypothesis was that functional avoidance radiotherapy could reduce the rate of ≥ grade 2 radiation pneumonitis to 12% compared to a 25% ≥ grade 2 historical pneumonitis rate. Based on a binomial, one-sided 95% confidence interval (CI), the trial would be positive if ≤ 11 of 67 patients (16.4%) experienced ≥ grade 2 radiation pneumonitis.”

With a median follow-up of 312 days, the study was statistically positive with 10 of 67 (14.9) ≥ grade 2 radiation pneumonitis events. Dr. Vinogradskiy concludes because 4-D CTs are a standard part of the treatment planning process for lung cancer patients, 4-D CT-ventilation offers an imaging modality that is convenient and provides functional imaging without an extra imaging procedure. This study provides favorable evidence for 4-D CT-ventilation functional avoidance to be investigated in a phase III study. However, Dr. Vinogradskiy and the team are still evaluating the possibility for the phase III trials in order to evaluate other related issues, for example, pulmonary function, patient-reported outcomes and imaging-based end-points.

Abstract 15 - Results of a Multi-Institutional Phase II Clinical Trial for 4-D CT-Ventilation Functional Avoidance Thoracic Radiotherapy was presented on October 24, 2021, during the SS 02 – Lung 1 session: Integration of Immunotherapy and Radiation Therapy for Non-small Cell Lung Cancer.

Published on: October 2021

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